- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615731
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
January 19, 2024 updated by: Stanford University
Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure.
The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require.
The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Jose, California, United States, 95128
- Santa Clara Valley Medical Center
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
Exclusion Criteria:
- Allergy to misoprostol or mifepristone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
|
Dilapan-S osmostic cervical dilators inserted through the internal os
Other Names:
400mcg buccal misoprostol 90 minutes pre-op
1mg digoxin administered intra-amniotically ~24 hours pre-op
|
Experimental: Mifepristone plus one set of dilators
One set of dilators plus mifepristone
|
Dilapan-S osmostic cervical dilators inserted through the internal os
Other Names:
400mcg buccal misoprostol 90 minutes pre-op
1mg digoxin administered intra-amniotically ~24 hours pre-op
200mg Mifepristone orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure Time
Time Frame: Intraoperative Time
|
Measured as time from speculum insertion to removal
|
Intraoperative Time
|
Total Procedure Time
Time Frame: Measured at clinic visits and on OR day, over a 3 day period
|
Measured at clinic visits and on OR day, over a 3 day period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Cervical Dilation
Time Frame: Measured intra-operatively
|
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
|
Measured intra-operatively
|
Adverse Events (EBL)
Time Frame: Intraoperatively
|
One adverse event: Estimated Blood Loss
|
Intraoperatively
|
Ease of Procedure by Blinded Surgeon
Time Frame: Measured Immediately after procedure
|
Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon.
The VAS ranges from 0-100.
0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
|
Measured Immediately after procedure
|
Pain Perceived by Patient
Time Frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
|
Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively).
The VAS ranges from 0-100.
0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
|
Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
|
Overall Patient Experience
Time Frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
|
Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience.
The VAS ranges from 0-100.
0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
|
Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
|
Adverse Events
Time Frame: Intraoperatively and 2 weeks post operatively
|
uterine perforation, uterine injury, etc.
|
Intraoperatively and 2 weeks post operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kate A Shaw, MD, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
May 30, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimated)
June 11, 2012
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Dilatation, Pathologic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Cardiotonic Agents
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Anti-Ulcer Agents
- Contraceptives, Oral, Synthetic
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Luteolytic Agents
- Abortifacient Agents, Steroidal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Menstruation-Inducing Agents
- Digoxin
- Misoprostol
- Mifepristone
Other Study ID Numbers
- SU-05302012-10088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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